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Clinical aspects of long-term follow-up of patients wtih Covid-19 after hospitalization in HC-Unicamp

Not Applicable
Conditions
Post-Acute COVID-19 Syndrome
Respiratory Insufficiency
C01.748
Registration Number
RBR-9s6zpjs
Lead Sponsor
niversidade Estadual de Campinas
Brief Summary

Introduction: The COVID-19 pandemic has accelerated the deployment of telehealth services to treat patients recovering from the disease. Objectives: To evaluate and compare the effectiveness of a Pulmonary Telerehabilitation Programme (PTRP) with fully remote versus hybrid (remote and face-to-face) supervision. Methods: This was a prospective, interventional, randomised clinical study carried out in a university hospital (Brazil) and approved by the institution's ethics committee. The study was carried out with patients who were hospitalised with severe COVID-19 and who, 90 days after hospital discharge, had a 6-minute walk test of <400m or a reduction in SpO2=4% throughout the test. Participants were randomised to PTRP with fully remote supervision (G1) or hybrid supervision (G2). The efficacy parameters were the 6-minute walk distance (6MWD) and quality of life (QoL) (SF-36). PTRP included structured exercises under remote supervision for 12 weeks, 3 sessions per week. Patients were assessed every 3 weeks, at the end and after 3 months of PTRP. The SF-36 was performed at the beginning and end of the PTRP. Results: Of the 246 patients assessed, 114 were eligible for PTRP; of these, only 49 started the programme and were randomised to receive either fully remote supervision (G1, n=28) or hybrid supervision (G2, n=21). The reason for not including all eligible patients was the unavailability of places on the PTRP due to pandemic-related limitations. There was a significant discontinuation rate, with only 13 patients from G1 and 17 from G2 completing the PTRP. The 37 eligible patients who were not included in the PTRP were re-evaluated and constituted a control group (CG). The initial 6MWD was similar between G1 (389m) and G2 (380m) (p=0.92). Both groups improved their QoL scores (physical component, p<0.02; emotional component, p<0.05); the 6MWD also increased in both groups (p<0.001) with increases of similar magnitude (G1=126m, G2=135m), p=0.8815. The 6MWD was used to compare the intervention group (IG) made up of all those who took part in the PTRP (G1+G2) and the control group (CG): there was no significant difference in the 6MWD between IG and CG at the pre-PTRP moment, but there was at the end of 6 months, when the IG had a significantly higher 6MWD than the CG group (p<0.001). GI increased the 6MWD by 140.5m, and CG by only 16.8m (p=0.002). Conclusions: PTRP was effective in improving the participants' functional capacity and QoL, with no difference between the supervision modalities. Severe post-COVID patients with reduced functional capacity showed a significant and lasting increase in 6MWD after PTRP, when compared to patients in clinical follow-up who received usual care

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruitment completed
Sex
Not specified
Target Recruitment
Not specified
Inclusion Criteria

Patients of both sexes; greater than or equal to 18 years old; diagnosis of severe COVID-19 who have been hospitalised; post-discharge outpatient assessment, have dyspnoea at rest; or a distance covered in the six-minute walk test of less than or equal to 400 metres and or 80% of that predicted using a predictive reference equation; or a drop in peripheral oxygen saturation of greater than or equal to 4 points

Exclusion Criteria

Osteoarticular or cognitive limitations; or patients with a tracheostomy; or patients with previous respiratory or cardiovascular diseases that prevent the participant from performing the proposed tests

Study & Design

Study Type
Intervention
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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